Synopsis
The Indian Health Ministry has halted the export of unapproved drug combinations by Aveo Pharmaceuticals and confiscated over 1.3 crore tablets to ensure public safety and compliance with regulations.Key Takeaways
- Export of unapproved drugs by Aveo Pharmaceuticals has been suspended.
- 1.3 crore tablets and various APIs have been seized.
- A Stop Production Order has been issued by the Maharashtra FDA.
- Export NOCs and Manufacturing Licenses are being revoked.
- CDSCO is revising its oversight procedures for drug exports.
New Delhi, Feb 23 (NationPress) The Health Ministry announced on Sunday that it has taken strong measures following reports regarding the export of unapproved combination drugs containing Tapentadol and Carisoprodol by the Indian pharmaceutical company, Aveo Pharmaceuticals, based in Mumbai, to various West African nations.
A collaborative team from the Central Drugs Standard Control Organisation (CDSCO) and the State Regulatory Authority conducted an extensive audit of Aveo Pharmaceuticals from February 21 to 22.
The audit results prompted the issuance of a Stop Activity Order, effectively ceasing all operations at the company's facility, as stated by the Health Ministry.
The investigation team confiscated all raw materials, in-progress materials, and finished products. Approximately 1.3 crore tablets/capsules and 26 batches of APIs (active pharmaceutical ingredients) of Tapentadol and Carisoprodol were detained to avert further distribution of these potentially hazardous drugs.
The Maharashtra FDA issued a Stop Production Order to Aveo Pharmaceuticals on February 22, 2025, effectively halting the manufacturing of the implicated drug combinations, according to the ministry.
Communications have been dispatched to all State Drugs Control Authorities and Zonal Offices, instructing them to promptly revoke Export NOCs and Manufacturing Licenses granted for any combination of Tapentadol and Carisoprodol. The same notifications were also sent to all Customs offices at designated ports to direct all shipments of the mentioned products through CDSCO Port offices.
An export shipment of Tapentadol 125 mg + Carisoprodol 100 mg, intended for Ghana, has been held at Mumbai Air Cargo pending further investigation.
To enhance future oversight, the CDSCO is revising the Export NOC checklist to ensure that either a Product Registration Certificate from the importing country's National Regulatory Agency (NRA) or approval from the Indian regulatory authority (CDSCO) is mandated for all medicines exported from India.
Since December 2022, the CDSCO, in partnership with state regulators, has initiated risk-based inspections of drug manufacturing and testing firms.
To date, 905 units have been inspected, resulting in 694 actions taken, including Stop Production Orders (SPO), Stop Testing Orders (STO), license suspensions or cancellations, warning letters, and show-cause notices, depending on the level of non-compliance.
This initiative has provided vital insights into manufacturing practices and has led to necessary corrective measures, resulting in observable improvements in the regulatory framework.
